AttraX® Putty in spinal fusion | Not Recruiting
AttraX® Putty in spinal fusion
NUVA.AX1101
Trial Source

Health Conditions
  • Degenerative conditions of the lumbar and cervical spine
Not Recruiting
Recruitment Status
ISRCTN38726728
Primary Trial ID Number
Summary
1. To evaluate the fusion rate following the use of AttraX®Putty in spinal fusion procedures performed at one or two contiguous level(s) of the cervical and lumbar spine. 2. To evaluate the complication rate associated with the use of AttraX®Putty compared to published and/or retrospective data for autograft, allograft, synthetics, bone morphogenic protein (BMP), or other graft alternatives. 3. To evaluate and identify any relationships between clinical outcomes (pain and function) and radiographic outcomes (fusion rate)
Primary Outcome Measures
  • The radiographic fusion rates at 12 months and 24 months
Secondary Outcome Measures
  • 1. The complication rate attributable to the use of AttraX® Putty
  • 2. The evaluation of angular displacement on flexion / extension films at the 6-, 12-, and 24-month follow-up visits
  • 3. The evaluation of bridging bone on computerised tomography (CT) at 12- and 24-month (as required) follow-up visits
  • 4. Preservation of interverterbal disc height over time
  • 5. The change in American Spinal Injury Association (ASIA) score from baseline at each follow-up visit
  • 6. The change in subject self-reported pain scores Visual Analogue Scale (VAS) from baseline at each follow-up visit
  • 7. The change in Neck Disability Index (NDI) or Oswestry Disability Index (ODI) scores from baseline at each follow-up visit
  • 8. The change in SF-36 scores from baseline at each follow-up visit
  • 9. Patient satisfaction at each follow-up visit
  • 10. The number of subjects returning to employment and the mean time of return to employment (as applicable)
Research Question
  • 1. To evaluate the fusion rate following the use of AttraX®Putty in spinal fusion procedures performed at one or two contiguous level(s) of the cervical and lumbar spine. 2. To evaluate the complication rate associated with the use of AttraX®Putty compared to published and/or retrospective data for autograft, allograft, synthetics, bone morphogenic protein (BMP), or other graft alternatives. 3. To evaluate and identify any relationships between clinical outcomes (pain and function) and radiographic outcomes (fusion rate)
Design Type
Sorry, this information is not available
Ethics Approval
Not provided at time of registration
Publications
Sorry, this information is not available
Countries of Recruitment
Germany; United Kingdom
Participant Sex
Both
Participant Age Range
Adult
Participant Type
Patient
Trial Sample Size
150
Participant Inclusion Criteria
  • 1. Persistent arm pain unresponsive to conservative treatment for at least 6 weeks or persistent back and/or leg pain unresponsive to conservative treatment for at least 6 months, unless surgical treatment is clinically indicated sooner
  • 2. Indicated for anterior cervical discectomy and fusion (ACDF), anterior lumbar interbody fusion (ALIF or XLIF), or posterior lumbar interbody fusion (PLIF or TLIF) at one or two contiguous motion segments (C3 to T1 in the cervical spine or L1 to S1 in the lumbar spine)
  • 3. Objective evidence of primary diagnosis must be confirmed by appropriate imaging studies
  • 4. 18-70 years of age at the date of written informed consent
  • 5. Able to undergo surgery based on physical exam, medical history and surgeon judgment
  • 6. Expected to survive at least 2 years beyond surgery
  • 7. Willing and able to return for post-treatment exams according to the follow-up called for in the protocol
  • 8. Signed and dated informed consent form
Participant Exclusion Criteria
  • 1. Mental or physical condition that would limit the ability to comply with study requirements
  • 2. Previous failed fusion at any spinal level
  • 3. Prior fusion procedure at operative level(s) (i.e. no revision of prior level)
  • 4. Prior instrumented fusion at level(s) adjacent to operative level(s)
  • 5. Systemic or local infection; active or latent
  • 6. Diseases that significantly inhibit bone healing (e.g., osteoporosis, metabolic bone disease)
  • 7. Treatment with pharmaceuticals interfering with calcium metabolism
  • 8. Undergoing chemotherapy or radiation treatment
  • 9. Chronic use of steroids (defined as more than 6 weeks of steroid use within 12 months of surgery, other than episodic use or inhaled corticosteroids)
  • 10. Involvement in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested)
  • 11. Significant general illness [e.g., human immunodeficiency virus (HIV), active metastatic cancer of any type, uncontrolled diabetes, dialysis dependent renal failure, symptomatic liver disease]
  • 12. Immunocompromised or is being treated with immunosuppressive agents
  • 13. Pregnant, or plans to become pregnant during the study
  • 14. A prisoner
  • 15. Participating in another clinical study that would confound study data
Interventions
1. Study Arm: Anterior Approach Cervical Interbody Fusion(ACDF) ACDF with CoRoent® Small Contoured or Small Lordotic Plus (SLP) and AttraX® Putty in the interbody space, and with NuVasive Helix ACPTM 2. Study Arm: Anterior Approach Lumbar Interbody Fusion eXtreme Lateral Interbody Fusion (XLIF) using CoRoent XL or Anterior Lateral Interbody Fusion (ALIF) using BrigadeTM or XLR implant(s) and AttraX® Putty in the interbody space, and with bilateral posterior stabilization by Armada® or SpheRx® pedicle screw system. 3. Study Arm: Posterior Approach Lumbar Interbody Fusion Bilateral or unilateral Posterior Lumbar Interbody Fusion (PLIF) or Transforaminal Lumbar Interbody Fusion (TLIF) using CoRoent Large or Large Oblique (LO) implant(s) (respectively) and AttraX® Putty in the interbody space, and with bilateral posterior stabilization by Armada or SpheRx pedicle screw system. All postoperative restrictions and rehabilitation of the subject are per the Investigator’s standard of care.
Design Details
Sorry, this information is not available
Study Design
Prospective non-randomized multi-arm observational study
Results Reporting
Sorry, this information is not available
Acronym
NUVA.AX1101
Scientific Title
AttraX® Putty in spinal interbody fusion: Evaluation of radiographic and clinical outcomes
Secondary Trial Identifying Number
NUVA.AX1101
Website
Sorry, this information is not available
Study Funded By
NuVasive, Inc. (USA)
Funder Type
Sorry, this information is not available
Study Sponsored By
NuVasive, Inc. (USA)
Study Also Sponsored By
Sorry, this information is not available
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment

01 Dec 2011

Recruitment End Date

01 Dec 2013

Trial End Date

01 Dec 2013

Date added to Registry

15 Dec 2011

Last Updated

20 Jun 2012